New Medical Devices Regulation & Risk Management

The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one.

Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate.

MDR highlights the importance of medical device risk management. Although risk management has been a requirement also in the MDD, it has never before been stated in such clear terms:

“/…/ in order to minimize risks or prevent incidents related to medical devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions./…/”

Annex I of the new MDR goes significantly into more details than the current MDDs:

“/…/ In carrying out risk management manufacturers shall:

(a) establish and document a risk management plan for each device;

(b) identify and analyse the known and foreseeable hazards associated with each device;

(c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;

(d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;

(e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and

(f) based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4. /…/”

These requirements are in line with ISO 14971, so they should not catch anyone by surprise.

The new regulation will apply three years after its formal publication, becoming mandatory by most likely early 2020. For Quality Management System regulation, the ISO 13485 that was released in 2016 will replace the earlier versions and become mandatory in early 2019.

For more information about medical device risk management system in Atlassian JIRA – SoftComply Risk Manager

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